United Therapeutics Q4 2020 Earnings Report
Key Takeaways
United Therapeutics Corporation reported a rise in full year net revenue to $1,483 million and U.S. patients being treated with the company's treprostinil-based therapies reached an all-time high during the fourth quarter.
Full year net revenue rose to $1,483 million.
U.S. patients being treated with the company's treprostinil-based therapies reached an all-time high during the fourth quarter.
Working toward four product launches this year, led by the recent launch of the Remunity® Pump.
INCREASE data in PH-ILD and our recent announcement of Tyvaso DPI clinical data, which suggest a comparable systemic treprostinil exposure to our approved Tyvaso Inhalation System.
United Therapeutics
United Therapeutics
United Therapeutics Revenue by Segment
Forward Guidance
In 2021, the company plans to launch four new products and indications.
Positive Outlook
- Launched commercial sales of the Remunity Pump for Remodulin in February 2021.
- Plan to launch a label expansion for Tyvaso, to include an indication for PH-ILD, assuming FDA approval in April 2021.
- Plan to launch the Implantable System for Remodulin, assuming the FDA grants the necessary clearances.
- Plan to launch Tyvaso DPI, assuming the FDA grants the necessary clearances.
- The voucher is expected to reduce the typical 12-month timeframe for FDA to review the Tyvaso DPI NDA to eight months.
Challenges Ahead
- Ability to launch the ISR in 2021, or at all, depends on the ability to work with Medtronic to satisfy the FDA's conditions and other factors, many of which are entirely outside of our control.
- Resubmission of our NDA for Trevyent will likely be delayed to 2022.
- Risk that we will not obtain the necessary FDA approvals to launch the products we expect to launch in 2021.
- The FDA clarified certain matters and indicated that a small clinical study of Trevyent in PAH patients may be required to evaluate further the pharmacokinetic profile and safety as correlated to the pump performance.
- We are assessing the FDA’s comments and awaiting additional written feedback from the agency.
Revenue & Expenses
Visualization of income flow from segment revenue to net income